BEUDAMED
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    PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15

    FDA 510(k)
    FDA Class 2 ·Radiology

    XLR

    FDA UDI
    Nuvasive, Inc.·00887517388261·XLR Trial, 18x38x28 8° Detachable

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083017248·STR, 10 electrode, MPD-S-M, 2-5-2mm electrode s...

    SCENARIA WHOLE-BODY X-RAY CT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNICORN MODEL SYS0630

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    TRUSTEEL

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    SUPERDIMENSION INREACH SYSTEM

    FDA Adverse Event
    Malfunction ·SUPERDIMENSION INC.·Product code JAK·May 8, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 17, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 21, 2012

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025